Quality Assurance Leadership Position for a Canadian Nanotechnology Company

13 hours ago

Guelph, Ontario, Canada People First HR Services Full time

Zentek is a Canadian company pioneering next-generation healthcare solutions through cutting-edge innovations in nanomaterials.

As a leader in molecular science, Zentek combines proprietary expertise with strategic partnerships to tackle complex global challenges in health, safety, and environmental protection.

The company fosters a dynamic, collaborative culture where curiosity, innovation, and commitment to excellence drive the team to create impactful solutions that protect and enhance people's lives.

This Quality Assurance Manager role will play a pivotal part in establishing and leading the Quality Assurance (QA) function at Zentek, contributing significantly to the company's growth and innovation.

In this position, you will oversee and advance Zentek's Quality Management System (QMS), ensure regulatory compliance, and lead quality initiatives that drive efficiencies and innovation across the organization.

You will have experience in quality management within the medical device or health-related sectors and be empowered to work closely with cross-functional teams.

Key responsibilities include:

  • Establishing and leading a high-performing QA team by recruiting, training, and mentoring members.
  • Managing and enhancing the QMS to ensure compliance with ISO 13485, MDEL, and MDSAP, while implementing process improvements.
  • Coordinating and conducting QMS management review meetings to review performance and identify areas for improvement.
  • Oversseeing document control to ensure accuracy, accessibility, and policy adherence.
  • Developing and managing quality control procedures for product release, including inspection, testing, and approvals.

Qualifications and key attributes include:

  • Bachelor's degree in engineering, science, or a related field; an advanced degree is preferred.
  • Minimum of 5 years in quality assurance within the medical device sector, with experience in a leadership or team-building capacity.
  • In-depth knowledge of ISO 13485, 21 CFR 820, and Canadian Medical Devices Regulations.
  • Familiarity with EU MDR 2017/745 and FDA 510(k) regulatory pathways is considered an asset.

The estimated salary for this position is $95,000 - $110,000 per annum, depending on qualifications and experience.

Benefits include dental care, extended health care, flexible schedule, life insurance, annual office expense reimbursement, and cell phone coverage.

Located in Guelph, Ontario, this role requires occasional travel and relocation to Canada.

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